Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
FDA 510(k) clearance K241745 · decided 2024-09-11
Clearance details
- K-number
- K241745
- Device name
- Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue)
- Applicant
- Ksg Medicare Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2024-06-18
- Decision date
- 2024-09-11
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tangkak, MY
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.